Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients

This study has been completed.

Sponsor:

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT01725724

First Posted: November 14, 2012

Last Update Posted: March 30, 2015

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Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.

Procedure: Allogeneic blood transfusion

Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.

Experimental: Autologous blood

Autologous blood transfusion. Patients in this arm will receive per- and postoperatively collected autologous blood collected with the Sangvia Blood Collection System. If teh amount of autologous blood is too small for the clinical need, additional allogeneic blood will be transfused.

Postoperative infections (both systemic and wound infections) are complications that should be avoided both due to the discomfort and the risk to the patients and for the corresponding increment of hospital costs.

There are some studies indicating that transfusion of autologous salvaged blood may reduce postoperative infections. This may be due to immunostimulating cytokines released in these products. However, as these cytokines also may cause adverse events as febrile transfusion reactions and activation of the complement and the coagulation cascades, the overall impact may be different.

There are two publications from an Austrian group indicating that allogeneic blood transfusion in orthopedic patients cause increased postoperative infection rate irrespectively of the leukocyte content of the red cell concentrates.

The Austrian studies were not randomized. Therefore, it would be useful to perform a randomized, prospective study where the patients receive transfusion of salvaged blood versus allogeneic red cell concentrate as their primary replacement product, respectively.

The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood reduces the infection rate in orthopedic patients compared with patients receiving allogeneic blood transfusion. The study is limited to one source of autologous blood; blood collected by the Sangvia Blood Collection System, and the study is partially sponsored by the manufacturer.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

16 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with a risk of needing red cell transfusion after surgery estimated to be above 75%, judged by preoperative hemoglobin concentration and known risk of preoperative bleeding

Patients over 16 years of age

Patients who have consented to participate

Exclusion Criteria:

Patients with a known hemolytic anemia (congenital or acquired)

Patients for whom informed consent has not been obtained

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725724